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Siemens Medical Solutions USA, Inc recalls SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography im
Recalled July 6, 2016 · FDA recall Z-2107-2016 · Siemens Medical Solutions USA
Hazard
Software issues. Siemens is voluntarily initiating a recall after they became aware of the following system behavior: 1) At times, the view and laterality marker is overlaid by patient demographic information, thus becoming difficult to read. 2) The facility name and address are not shown per default (in the current software versions this information is displayed only when the reader chooses an appropriate image text display mode). · FDA Class II
Units
29 units
Sold at
Distributed to: CA,NY,TX,OH,CO,NY,TX,CA,NE,NJ,TX,FL,IL,TX,MO,CA,PA,FL,NJ,MO,ND
Description
Software issues. Siemens is voluntarily initiating a recall after they became aware of the following system behavior: 1) At times, the view and laterality marker is overlaid by patient demographic information, thus becoming difficult to read. 2) The facility name and address are not shown per default (in the current software versions this information is displayed only when the reader chooses an appropriate image text display mode).
Product
SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →